FDA Advisory Committee decision limits scope of Praluent (alirocumab) to limit the recommended approval to treatment of heterozygous familial hypercholesterolemia- Sanofi + Regeneron.

The effect of the FDA Endocrinologic and Metabolic Drugs Advisory Committee ( EMDAC) decision for Praluent (alirocumab) from Sanofi + Regeneron is to limit the recommended approval to treatment of heterozygous familial hypercholesterolemia - the genetic disease that causes high levels of LDL-C at a young age and of those at a high CV risk where statins are inadequate. Sanofi + Regeneron hope to secure approval for the drug for primary hypercholesterolemia- non familial and HeFH or mixed dyslipidaemia including those patients with type 2 diabetes. The EMDAC held that the FDA should wait for the cardiovascular outcomes trial ODYSSEY OUTCOMES before releasing the drug for the wider population.

Comment: Dr Abraham Thomas, chairman of the Department of Medicine at New York University Lutheran in Brooklyn, predicted Sanofi and Regeneron may have trouble marketing their injectable drug without the CVOT data. "It's hard enough to get patients to take statins . . . an oral med once a day. It's going to be harder to get someone to take an injection once every two weeks without convincing data," according to Dr Thomas.